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ID
Source
Brief title
Health condition
Opioid induced respiratory depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
repsiratory depression
Secondary outcome
pain pressure treshold
Background summary
Tapentadol is a centrally acting analgesic with two mechanisms of action: a μ-opioid receptor agonism and noradrenaline (NA) reuptake inhibition. Although the binding of tapentadol to the μ-opioid receptor is weaker than that of morphine its analgesic action is similar to that of morphine due to the (synergistic) effect of the second mechanism (i.e., NA reuptake inhibition). As the effects on of opioid analgesics are attributed to μ-opioid receptor agonism, tapentadol should produce less respiratory depression at equi-analgesic doses.
Study objective
At equi-analgesia respiratory depression from oxycodone is manifold greater compared to Tapentadol
Study design
6 respiratory measurements will be obtained lasting 30 minutes at 1 hour intervals. pain tests will be obtained every half hour following administration of the study drug.
Intervention
Healthy volunteers will be administered Tapentadol in two doses, oxycodone or placebo. Hypercapnic ventilatory response curves will be obtained as well as pain pressure tests
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Inclusion criteria
Age of 18 to 45 years (inclusive);
Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive)
body weight between 50 kg and 100 kg (inclusive);
Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
Subject is willing to comply with study restrictions
Exclusion criteria
Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);
A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening;
History of alcoholism or substance abuse within three years prior to screening;
Positive pregnancy test;
Positive drug screening or alcohol breath test;
Subjects using more than 21 units of alcohol per week;
Use of medication during the study period;
If sexually active, the subject is not using contraceptives, or surgically sterilized;
Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
Participation in an investigational drug trial in the 2 months prior to administration of the initial dose of study drug or more than 5 times per year;
Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject:
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4736 |
| NTR-old | NTR5076 |
| Other | : |